A Double-Blind, Group-Comparison Study Using Zolpidem (Myslee) as a Comparative Drug in Patients With Insomnia

Condition(s) targeted: Sleep Initiation and Maintenance Disorders; Sleep Disorders

Intervention: Zolpidem MR (Drug); Zolpidem (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Central Contact, Study Chair, Affiliation: Astellas Pharma Inc

The purpose of this study is to investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) in patients with insomnia by a randomized, double-blind, group-comparison study using zolpidem (Myslee) as a comparative drug

Official title: FK199B (Zolpidem MR Tablet) Phase III Clinical Study -A Double-Blind, Group-Comparison Study Using Zolpidem (Myslee) as a Comparative Drug in Patients With Insomnia -

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Mean wake time after sleep onset during the double-blind period

Secondary outcome:

Mean total sleep time during the double-blind period

Mean number of nightly awakenings during the double-blind period

Mean sleep latency during the double-blind period

Patient impression during the double-blind period

Safety

Minimum age: 20 Years. Maximum age: 64 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Clinical diagnosis of nonorganic insomnia.

- Must be able to swallow tablets

Exclusion Criteria:

- Allergic reactions to zolpidem (Myslee)

- Serious cardiac disorders; Serious hepatic impairment; Serious renal diseases, etc.

Hokkaido region, Japan

Tohoku region, Japan

Kanto region, Japan

Chubu region, Japan

Kansai region, Japan

Chugoku region, Japan

Shikoku region, Japan

Kyushu region, Japan

Starting date: February 2006
Ending date: November 2007
Last updated: February 6, 2008